Preparation and quality control of enoxaparin sodium:
First of all, the starting raw material from heparin sodium crude, enzymatic hydrolysis, oxidation, resin adsorption elution, drying, to prepare the heparin sodium boutique; The final product enoxaparin was prepared by the preparation of heparin - benzochloramine salt, heparin - benzyl ester, and the subsequent β elimination degradation, oxidation decolorization, lyophilization, etc.
For in accordance with the quality control of heparin, the most important for "molecular weight average molecular weight and its distribution", in addition to the impurity control, especially the skin pigment sulfate, chondroitin sulfate and so on more likely to cause adverse reactions of impurity control, therefore, removing impurity and determine the molecular weight and its distribution is the key to ensure the quality of the process control.